NCT00762853已完成3 期
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Triclosan Concentration in Dental Plaque
研究概览
简要总结
The objective is to develop a method to determine active ingredient uptake in oral care products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteer 18 - 65 years of age (inclusive).
- •Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars)
- •Able and willing to sign the informed consent form.
- •Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.
- •No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
排除标准
- •Medical condition which requires pre-medication prior to dental procedures/visits
- •Medical condition which precludes not eating/drinking for 2 hours
- •Advanced periodontal disease (gum disease)
- •5 or more decayed, untreated dental sites (cavities)
- •Diseases of the soft or hard oral tissues
- •Orthodontic appliances
- •Abnormal salivary function
- •Use of drugs that can affect salivary flow
- •Use of antibiotics one (1) month prior to or during this study
- •Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn, etc)
- •Pregnant or breastfeeding.
- •Participation in another clinical study in the month preceding this study
- •Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
研究组 & 干预措施
A
Placebo Comparator
fluoride toothpaste from Thailand
干预措施: Fluoride (Drug)
B
Active Comparator
fluoride/triclosan/copolymer toothpaste
干预措施: Fluoride and triclosan (Drug)
结局指标
主要结局
Triclosan Concentration in Dental Plaque
时间窗: 12 hours
Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.
次要结局
未报告次要终点
研究者
研究点 (1)
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